Catalog Number 60593 |
Device Problems
Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that the bd gp series infusion set had split that caused leaking.The following information was provided by the initial reporter: i came to bedside and found small puddle on the floor, when i looked the paracetamol was dripping onto the floor as the iv giving set had split.
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Manufacturer Narrative
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Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 9616066-2022-01456 was sent in error.This device is manufactured in a facility that does not manufacture devices for the us market.These devices are sold outside of the us and are not similar to bd devices registered or sold in the us.Therefore, this is exempt from us fda reporting requirements.
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Event Description
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It was reported that the bd gp series infusion set had split that caused leaking.The following information was provided by the initial reporter: i came to bedside and found small puddle on the floor, when i looked the paracetamol was dripping onto the floor as the iv giving set had split.
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Search Alerts/Recalls
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